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27 November 2024 The strain of opioid use disorder (OUD), a chronic neurological disorder characterized by the compulsive, repeated use of opioid drugs, has weighed heavily on many countries in recent years, especially the USA.
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Biotechnology
PTC Therapeutics is to sell its rare pediatric disease priority review voucher (PRV) for $150 million. 28 November 2024
Biotechnology
A report from industry analyst DelveInsight highlights progress in the myotonic dystrophy treatment landscape, with more than 20 companies developing over 22 innovative treatments. 28 November 2024
Biotechnology
The UK subsidiary of Dutch drugmaker argenx confirmed today that its investigational therapy, subcutaneous efgartigimod alfa has been granted Promising Innovative Medicine (PIM) designation by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP). 28 November 2024
Biotechnology
Privately-held French drugmaker Servier has announced the inauguration of its first unit dedicated to the production of biological medicines from its R&D pipeline. 28 November 2024
Biotechnology
The US Food and Drug Administration has received new reports of hematologic malignancies, including life-threatening cases of myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), following treatment of early, active cerebral adrenoleukodystrophy (CALD) patients with Skysona (elivaldogene autotemcel). 28 November 2024
Biotechnology
San Diago, USA-based Acadia Pharmaceuticals yesterday announced it has entered into an exclusive worldwide license agreement with Denmark’s Saniona for the development and commercialization of SAN711, a first-in-class, highly selective GABAA-α3 positive allosteric modulator. 28 November 2024
Biotechnology
Kronos Bio, a biotech with a presence on the east and west coasts of the USA, has unveiled a major restructuring plan. 28 November 2024
Biotechnology
Johnson & Johnson has made significant strides in multiple myeloma treatment, with breakthroughs in targeted therapies like CAR-T and bispecific antibodies. At the 2024 ASH meeting, J&J aims to showcase progress, with a goal of achieving a functional cure for multiple myeloma. 28 November 2024
Biotechnology
The European medicines regulator has approved a combo therapy starring PD-1 inhibitor Tevimbra (tislelizumab), from cancer firm BeOne Medicines, formerly BeiGene. 27 November 2024
Biotechnology
After trading closed yesterday, Exelixis revealed that the US Food and Drug Administration (FDA) has notified the company that the supplemental New Drug Application (sNDA) for cabozantinib (Cabometyx) for the treatment of adults with previously treated advanced pancreatic neuroendocrine tumors (pNET) and advanced extra-pancreatic NET (epNET) will be discussed at an Oncologic Drugs Advisory Committee (ODAC) meeting in March 2025. 27 November 2024
Biotechnology
Chengdu-based Kelun-Biotech has received marketing authorization in China for sacituzumab tirumotecan (sac-TMT), a Trop2-directed antibody-drug conjugate (ADC). 27 November 2024
Biotechnology
AI-powered protein engineering company Cradle has raised $73 million in a Series B funding. The European firm, which has now raised more than $100 million in total, calls itself the leading platform for AI-powered protein engineering. 27 November 2024
Biotechnology
US clinical stage biotech Alector saw its shares tumble 35% to $2.57 by close of trading yesterday, as it announced disappointing results from the INVOKE-2 Phase II clinical trial evaluating the safety and efficacy of AL002 in slowing disease progression in individuals with early Alzheimer’s disease (AD). 27 November 2024
Biotechnology
PTC Therapeutics has announced that its Phase II trial for utreloxastat, aimed at treating amyotrophic lateral sclerosis (ALS), failed to meet its primary endpoint. 27 November 2024
Biotechnology
US companies Arrowhead Pharmaceuticals and Sarepta Therapeutics have announced a global licensing and collaboration agreement. 26 November 2024
Biotechnology
Clinical-stage US CAR-T therapies developer Poseida Therapeutics saw its shares skyrocket 227% to $9.36 pre-market today, on the news of a proposed takeover by Swiss pharma giant Roche. 26 November 2024
Biotechnology
Replimune, a clinical-stage biotech focused on oncolytic immunotherapies, has announced plans to raise $125 million through a public offering. 26 November 2024
Biotechnology
Chinese gene therapy firm Kanglin Biotechnology has completed a $20 million series A financing round, with the money earmarked for KL003, an innovative treatment for blood disorders. 26 November 2024
Biotechnology
BRL Medicine, a Shanghai-based biotechnology company specializing in cell and gene therapies, has raised nearly 200 million yuan ($27 million) in a series B+ round led by CSPC Fund. 26 November 2024
Biotechnology
Italian oncology focused biotech Nerviano Medical Sciences yesterday announced that it has successfully negotiated with Germany’s Merck KGaA to buy back the full world-wide rights of NMS 293 (also known as NMS-03305293). 26 November 2024
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Biotechnology
Arrowhead Pharmaceuticals’ shares were up more than 55% at $52.43 late-morning, after it released positive Phase II interim results on RNAi candidate ARO-AAT for the treatment of liver disease associated with alpha-1 antitrypsin deficiency, that even surprised the US biotech company’s researchers 16 September 2020
Biotechnology
GenSight Biologics, a French biopharma focused on discovering and developing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, has announced that it has submitted the Marketing Authorisation Application (MAA) for its lead product to the European Medicines Agency (EMA). 16 September 2020
Biotechnology
Influenza prevention specialist Seqirus, part of Australia’s CSL Limited, today announced the publication of real-world evidence (RWE) on the company's cell-based quadrivalent influenza vaccine (QIVc) in peer-reviewed medical journal Vaccine. 16 September 2020
Biotechnology
The CPhI predicts dramatic growth of new monoclonal antibody (Mab) production in China, capacity shortages for cell and gene therapies in the USA, and the widespread global adoption of single-use technologies, in its latest annual report, launched ahead of the first CPhI Festival of Pharma (October 5-16, 2020). 16 September 2020
Biotechnology
Privately-held Finnish company Forendo Pharma has announced that Cristina Csimma has been appointed chairwoman of the board of directors. 16 September 2020
Biotechnology
Cancer specialist AVEO Oncology has published final overall survival (OS) results from the Phase III TIVO-3 study of tivozanib in kidney cancer. 16 September 2020
Biotechnology
While British drugmaker AstraZeneca has resumed clinical testing for its coronavirus vaccine candidate in the UK, authorities in the US are set to keep the trial on hold for a few more days at least. 16 September 2020
Biotechnology
Japan’s largest drugmaker Takeda Pharmaceutical says it has expanded its US cell therapy manufacturing capabilities with the opening of a new 24,000 square-foot R&D cell therapy manufacturing facility at its R&D headquarters in Boston, Massachusetts. 16 September 2020
Biotechnology
US biotech Novavax’ shares were up nearly 6% at $111.90 late morning on Tuesday, after it announced an amendment to its existing agreement with the Serum Institute of India Private (SII) under which the latter will also manufacture the antigen component of NVX CoV2373, Novavax’ COVID 19 vaccine candidate. 16 September 2020
Biotechnology
In the ultra competitive space of anti-calcitonin gene-related peptide (CGRP) monoclonal antibody drugs for the treatment of migraines, every little helps. 15 September 2020
Biotechnology
German company BioNTech was trading 2% higher in early trading on Tuesday. 15 September 2020
Biotechnology
A major agreement between I-Mab and AbbVie will see the firms working together in oncology. 15 September 2020
Biotechnology
San Diego, USA-based Escient Pharmaceuticals, which is developing Mas-related G Protein-Coupled Receptor (MRGPR)-targeted drugs to address serious, underserved medical needs across a broad range of therapeutic indications, today announced the completion of a $77.5 million Series B financing. 15 September 2020
Biotechnology
Despite a range of online resources to facilitate interactions between attendees, there clearly won’t be the same opportunities for networking at this year’s annual congress of the European Society of Medical Oncology (ESMO). 15 September 2020
Biotechnology
Shares of US biotech firm Seattle Genetics closed up 14.5% to $171.79 on Monday after the company revealed a cancer collaboration with US pharma giant Merck & Co that includes a $1 billion investment in the company and could be worth $4.2 billion in total. 15 September 2020
Biotechnology
The US Food and Drug Administration has granted Rare Pediatric Disease designation to Ad-RTS-hIL-12 with veledimex (Controlled IL-12) for the investigational treatment of diffuse intrinsic pontine glioma (DIPG), a lethal brain tumor occurring in the pontine region of the brain. 14 September 2020
Biotechnology
CNS specialist Neuraxpharm has acquired the prescription brand Buccolam (oromucosal midazolam) from Japanese pharma major Takeda. 14 September 2020
Biotechnology
Swiss pharma giant Novartis has reported the first interpretable results of the Phase III KITE study, assessing the efficacy and safety of Beovu (brolucizumab) 6 mg in diabetic macular edema (DME). 14 September 2020
Biotechnology
The Institute for Clinical and Economic Review (ICER) has released an Evidence Report assessing the comparative clinical effectiveness and value of several targeted immune modulators (TIMs) that treat ulcerative colitis (UC). 14 September 2020
Biotechnology
Valneva has announced a partnership with USA-based Dynavax Technologies for the supply of Dynavax' CpG 1018 adjuvant for use in Valneva's SARS-CoV-2 vaccine candidate, VLA2001 14 September 2020
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